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ClinicalTrials.gov Identifier: NCT01177969

Recruitment Status :
Completed

First Posted : August 9, 2010

Results First Posted : July 1, 2014

Last Update Posted : July 1, 2014

Sponsor:

University of South Florida

Collaborators:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.

Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.

A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.

Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.

The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.

Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.

A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.

Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.

The Pediatric Anxiety Rating Scale is a clinician-rated scale assessin...

Description

The Pediatric Anxiety Rating Scale is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week. The scale includes 5 items which are summed to form a total score, which represents anxiety severity. The scale score ranges from 0 to 25 with higher scores indicating more severe anxiety symptoms.

Time Frame

Post-treatment, which is an average of 16 weeks after Baseline

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

[Not Specified]

Arm/Group Title

Cognitive-Behavioral Therapy

Wait-list

Arm/Group Description:

The form of treatment will involve ...

A wait-list essentially involves no...

Arm/Group Description:

The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.

Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.

A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.

Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.

Overall Number of Participants Analyzed

19

14

Mean (Standard Deviation)

Unit of Measure: units on a scale

11.62
(3.26)

14.04
(2.64)

Statistical Analysis 1
Statistical Analysis 1

Statistical Analysis Overview

Comparison Group Selection

Cognitive-Behavioral Therapy, Wait-list

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

.04

Comments

This analysis applies to the post-treatment assessment (16 weeks after baseline)

The Anxiety Disorders Interview Schedule: Child and Parent Versions are clinician-rated scales assessing anxiety symptoms and the associated severity and impairment in children over the past month. The clinician interviewer interviews the child and parent separately about the nature and severity of the child's anxiety. If a child meets criteria for an anxiety disorder, a single item is rated by the interviewer, which represents anxiety severity. The scale score for this single item ranges from 0 to 8 with higher scores indicating more severe anxiety symptoms.

Time Frame

Post-treatment, which was an average of 16 weeks after Baseline

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

[Not Specified]

Arm/Group Title

Cognitive-Behavioral Therapy

Wait-list

Arm/Group Description:

The form of treatment will involve ...

A wait-list essentially involves no...

Arm/Group Description:

The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.

Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.

A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.

Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.

Overall Number of Participants Analyzed

19

14

Mean (Standard Deviation)

Unit of Measure: units on a scale

3.28
(2.1)

4.04
(1.88)

Statistical Analysis 1
Statistical Analysis 1

Statistical Analysis Overview

Comparison Group Selection

Cognitive-Behavioral Therapy, Wait-list

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

.25

Comments

This analysis applies to the post-treatment assessment (16 weeks after baseline)

The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.

Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.

A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.

Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.

All-Cause Mortality

Cognitive-Behavioral Therapy

Wait-list

Affected / at Risk (%)

Affected / at Risk (%)

Total

--/--

--/--

Serious Adverse Events Serious Adverse Events

Cognitive-Behavioral Therapy

Wait-list

Affected / at Risk (%)

Affected / at Risk (%)

Total

0/19 (0.00%)

0/14 (0.00%)

Other (Not Including Serious) Adverse Events Other (Not Including Serious) Adverse Events